Chronic Myelogenous Leukemia (NCT03578367)
A Phase II, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
|This study is recruiting: Phase II||Actual Start Date: [November 22, 2018]||Estimated Completion Date: [October 20, 2021]||Novartis Reference Number: CABL001E2201|
|Condition: Chronic Myelogenous Leukemia in Chronic Phase||Interventions: asciminib, nilotinib, imatinib||Estimated Enrollment: [120 participants]||ClinicalTrials.gov Identifier: NCT03578367|
|This study is recruiting: Phase II||Actual Start Date: [November 22, 2018]|
|Estimated Completion Date: [October 20, 2021]||Novartis Reference Number: CABL001E2201|
|Condition: Chronic Myelogenous Leukemia in Chronic Phase||Interventions: asciminib, nilotinib, imatinib|
|Estimated Enrollment: [80 participants]||ClinicalTrials.gov Identifier: NCT03578367|
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP).
Participants may be eligible to participate if they:
- Are 18 years or older
- Have Confirmed diagnosis of CML-CP
- Have Minimum of 2 years treatment with imatinib first line for CML-CP
- BCR-ABL1 ratio ≥ 0.01% IS and ≤ 1% IS at the time of study entry
- Must not have achieved deep molecular response (MR4) at any time during prior imatinib therapy
- Meet other eligibility criteria
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
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Last Updated: May 1, 2019